The FDA wants to assign LDTs a risk classification of low
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A year after the FDA proposed regulating “high-risk” laboratory-developed tests (LDTs) along the lines of Class III medical devices, through draft guidances friendlier to for-profit diagnostic developers than nonprofit academic medical centers, both sides have advanced detailed regulatory counterproposals in hopes of swaying the agency.

The Association for Molecular Pathology (AMP), whose membership includes academic and community medical centers, has released its own recommended rules for LDTs. AMP contends that the FDA is overreaching in its proposed regulation of LDTs—which it calls “laboratory-developed testing procedures”—because the tests are not medical devices subject to the Food, Drug, and Cosmetic Act (FDCA).

Instead, the AMP is advocating the most extensive updates to the Clinical Laboratory Improvement Amendments of 1998 (CLIA) since they took effect in phases through 1994, with the goal of accommodating current laboratory practices and technology. Labs may develop and use their own diagnostic tests internally, without FDA oversight, if certified under the waiver program of CLIA, overseen by the Centers for Medicare and Medicaid Services (CMS).

The AMP’s “Proposal for Modernization of CLIA Regulations for Laboratory Developed Testing Procedures” creates a three-tier, risk-based regulatory system for LDTs. Labs can validate “low risk” tests and put them into service, subject to inspection in the normal course of the inspection process.

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